Nerve Stimulation to Help Stroke Patients Come Off a Breathing Machine
Tests non-invasive phrenic nerve stimulation in adults with stroke who need a breathing machine.
Key facts
- Who runs it
- Xuanwu Hospital, Beijing
- Where
- Beijing and Shijiazhuang, ChinaSee the 9 sites
- Trial code
- Registry title
- Phrenic Nerve Stimulation for Reducing Ventilation Duration in Acute Cerebral Infarction: A Multicenter Randomized Controlled Trial
- Status
- Not yet recruiting
- People taking part
- 590 people, planned
- Started
- 1 Sept 2025
- Expected to end
- 31 Dec 2027
- Type of study
- Interventional, 2 groupsOne group gets a sham (pretend) treatment, for comparison.
- Treatments tested
- Transcutaneous electrical phrenic nerve stimulation
- Sham (No Treatment)
- Record updated
- 21 August 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a recent stroke caused by a blocked brain artery (acute cerebral infarction) who are on a breathing machine (ventilator). It tests a gentle electrical stimulation of the nerve that moves the breathing muscle.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Acute cerebral infarction, confirmed by head CT or MRI, within 30 days of onset. On mechanical ventilation for 24 hours or more.
Main reasons for not taking part
- Other serious conditions that affect the diaphragm, such as severe malnutrition or irreversible phrenic nerve damage
- Severe lung disease or severe heart failure (NYHA Class IV)
- Sepsis or shock needing high-dose vasopressors
- Expected survival of 7 days or less
- Pacemaker implanted, or pregnant or breastfeeding
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- age ≥ 18 years old
- no gender restrictions
- patient diagnosed with acute cerebral infarction (within 30 days of onset) through cranial CT or MRI
- duration of mechanical ventilation ≥ 24 hours
- patient or their legal guardian agrees to participate in the study and signs an informed consent form
Who cannot take part
- previous presence of severe lung disease (such as severe COPD, interstitial lung disease, pulmonary embolism, etc.), severe heart failure (NYHA Class IV)
- there are other significant conditions that affect diaphragm function, such as severe malnutrition, irreversible respiratory pump failure caused by medullary or cervical cord injury, and irreversible damage to the phrenic nerve
- severe skin damage or infection at the electrode placement site
- the terminal state of the disease or expected survival period does not exceed 7 days
- significant agitation cannot be combined with transcutaneous electrical phrenic nerve stimulation
- sepsis or shock requiring high-dose vasopressors
- pacemaker implantation
- pregnant or lactating women
- patients whose family members express their willingness to withdraw for treatment
Where in China
- Beijing Daxing District People's HospitalBeijing, ChinaContact: Huiliang YangNo longer taking part
- Beijing Ditan Hospital, Capital Medical UniversityBeijing, ChinaContact: Meijuan JiangNo longer taking part
- Beijing Hui Min HospitalBeijing, ChinaContact: Yanbo HeNo longer taking part
- Beijing Tongren Hospital, Capital Medical UniversityBeijing, ChinaContact: Qinglin YangNo longer taking part
- Dongzhimen Hospital, Beijing University of Chinese MedicineBeijing, ChinaContact: Yanen LvNo longer taking part
- Sanbo Brain Hospital, Capital Medical UniversityBeijing, ChinaContact: Zhonghua ShiNo longer taking part
- The First Hospital of Fangshan DistrictBeijing, ChinaContact: Liang ChenNo longer taking part
- Xuanwu Hospital, Capital Medical UniversityBeijing, ChinaContact: Linlin FanNo longer taking part
- The First Hospital of Heibei Medical UniversityShijiazhuang, ChinaContact: Ya ChangNo longer taking part
About the trial
What the trial wants to find out
The goal of this clinical trial is to learn if non-invasive phrenic nerve stimulation works in adult acute cerebral infarction participants undergoing mechanical ventilation. It will also learn about the safety of non-invasive phrenic nerve stimulation. The main questions it aims to answer are：
Read full original descriptionShow less
1. Can non-invasive phrenic nerve stimulation shorten the duration of ventilator use and improve long-term prognosis? 2. What medical problems do participants have when taking non-invasive phrenic nerve stimulation? Researchers will compare non-invasive phrenic nerve stimulation to a sham stimulation to see if non-invasive phrenic nerve stimulation works.
Participants will:
1. Receive 14 days of non-invasive phrenic nerve stimulation or sham stimulation 2. Visit the clinic or call for follow-up at 90 days of onset
The 2 groups in the trial
- Intervention groupTreatment being tested
Transcutaneous electrical phrenic nerve stimulation for 14 days
Treatment: Transcutaneous electrical phrenic nerve stimulation
- Control groupSham treatment, for comparison
Sham stimulation for 14 days
Treatment: Sham (No Treatment)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Transcutaneous Electrical Phrenic Nerve Stimulation for Reducing Mechanical Ventilation Duration in Acute Cerebral Infarction: A Multicenter Randomized Controlled Trial
- Plain-language title
- Nerve Stimulation to Help Stroke Patients Come Off a Breathing MachineGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 21 August 2025